Canexis Pharma AG is a Swiss start-up company in the field of phytopharmacy with a focus on medical cannabis. The company produces high-quality plant extracts and specializes in their refinement and processing. The product range of this vertically integrated full-service provider of pharmaceutical cannabis products includes cannabidiol (CBD), dronabinol (THC), and standardized medicinal bases. To maintain the highest quality, Canexis relies on deep process knowledge, clean rooms, and state-of-the-art systems.
gempex supports Canexis Pharma AG.
The company planned to set up a new production facility in a new building for the manufacture of cannabis oils for the pharmaceutical and cosmetics industries. This required obtaining an establishment license in accordance with GMP.
gempex was involved in this new construction project from the initial idea to the successfully issued establishment license as the GMP lead partner. GMP design, layout, qualification, design and implementation of QMS, validation, as well as inspection preparation and support were the typical and essential stages. In some cases, also the tasks of an outsourced QA had to be taken over.
The qualification and validation concept was developed and implemented in particularly close cooperation with the customer. From the outset, the general planner and systems suppliers were involved in the GMP requirements. With a team of experts that was flexibly reinforced as needed, gempex took on the tasks comprehensively and with foresight.
Efficiency in qualification was achieved through the early involvement of the technical systems suppliers. All elements required for compliant cannabis production were precisely planned and implemented. In this way, a completely new QMS was established unerringly. Mock inspection, employee training, and support during the inspection ensured the final success.
Having successfully passed the inspection and been issued an establishment license by Swissmedic, Canexis was able to start production quickly.
This is an example of a successful overall Full-GMP-Service project, in which the client also played a significant role.
Key Performances of gempex in this project were:
- GACP and GMP consulting
- URS, risk analyses
- Validation master planning
- QMS concept
- Creation of quality management manual and SOPs
- Software validation
- Qualification: DQ, IQ, OQ, PQ
- Process validation
- Master document SMF
- Training
- Inspection support
For any questions on the topic GMP for Cannabis or GMP Consulting, Ralf Gengenbach, Managing Director of gempex GmbH, will be happy to be contacted via contact@gempex.com.
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